What is the AAMI standard for endotoxin levels in conventional dialysate?

• A. Less than 2 EU/mL
• B. Less than 5 EU/mL
• C. Less than 0.5 EU/mL
• D. Less than 10 EU/mL

Answer: (A)

Endotoxin control in dialysate is crucial because endotoxins from bacteria can trigger fever and inflammatory responses during dialysis. For conventional dialysate, the established limit is less than 2 endotoxin units per milliliter (EU/mL). This threshold helps keep patient exposure safe during standard sessions. Dialysate is produced from treated water and routinely tested, often with a Limulus amebocyte lysate (LAL) assay, before use. In ultrapure dialysate, the endotoxin limit is much tighter (around 0.03 EU/mL), reflecting higher purity requirements. The other listed values don’t represent the conventional-dialysate standard, since they either permit more endotoxin than allowed or demand a stricter limit than what AAMI specifies for conventional dialysate.